Category

Medical Implants Recalls

1,784 medical implants recalls on record from CPSC, FDA, and USDA.

1,784 recalls
High RiskFDA
Straumann Usa Llc
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Medical Implants·6 affected·Mar 27, 2026
High RiskFDA
Straumann Usa Llc
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
Medical Implants·5 affected·Mar 27, 2026
High RiskFDA
Advanced Bionics, Llc
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-...
Medical Implants·45,173 affected·Mar 23, 2026
High RiskFDA
Centinel Spine, Inc.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Medical Implants·30 affected·Mar 20, 2026
High RiskFDA
Centinel Spine, Inc.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
Medical Implants·30 affected·Mar 20, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO ...
Medical Implants·718,456 affected·Mar 19, 2026
High RiskFDA
Medline Industries, Lp
Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, ...
Medical Implants·38,014 affected·Feb 25, 2026
High RiskFDA
Clariance-sas
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3...
Medical Implants·511 affected·Feb 20, 2026
High RiskFDA
B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A devi...
Medical Implants·51,300 affected·Feb 2, 2026
High RiskFDA
B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Descrip...
Medical Implants·21,000 affected·Feb 2, 2026
High RiskFDA
Staar Surgical Ag
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Medical Implants·7 affected·Jan 21, 2026
High RiskFDA
Encore Medical, Lp
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Numbe...
Medical Implants·20 affected·Jan 15, 2026
High RiskFDA
Encore Medical, Lp
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 50...
Medical Implants·20 affected·Jan 15, 2026
High RiskFDA
Medline Industries, Lp
Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117...
Medical Implants·4,757 affected·Jan 7, 2026
High RiskFDA
Miach Orthopaedics
BEAR Implant. Model Number: 1000.
Medical Implants·284 affected·Dec 31, 2025
CriticalFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Medical Implants·266 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Medical Implants·557 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Medical Implants·588 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Medical Implants·39 affected·Dec 19, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lum...
Medical Implants·148 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lu...
Medical Implants·179 affected·Dec 11, 2025
High RiskFDA
C.r. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Medical Implants·116 affected·Nov 6, 2025
High RiskFDA
C.r. Bard Inc
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Medical Implants·116 affected·Nov 6, 2025
High RiskFDA
C.r. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Medical Implants·4,350 affected·Nov 6, 2025
High RiskFDA
Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Medical Implants·6,591 affected·Oct 29, 2025
CriticalFDA
Tmj Solutions Inc
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Medical Implants·63 affected·Oct 13, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106...
Medical Implants·35,376 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller...
Medical Implants·2,424 affected·Oct 9, 2025
High RiskFDA
Thoratec Llc
Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Co...
Medical Implants·248 affected·Oct 9, 2025
High RiskFDA
Abbott Medical
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Medical Implants·20,715 affected·Oct 6, 2025
High RiskFDA
Abbott Medical
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Medical Implants·722 affected·Oct 6, 2025
High RiskFDA
Medline Industries, Lp
MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS860015W; 2) MAJOR LAPAROTOMY CDS, REF CDS860015X; 3) MINOR LA...
Medical Implants·28,679 affected·Sep 30, 2025
High RiskFDA
Dsaart Llc
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B49...
Medical Implants·35 affected·Sep 26, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110...
Medical Implants·72 affected·Sep 26, 2025
High RiskFDA
Dsaart Llc
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI c...
Medical Implants·2 affected·Sep 26, 2025
High RiskFDA
Zimmer, Inc.
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110...
Medical Implants·63 affected·Sep 26, 2025
High RiskFDA
Dsaart Llc
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implan...
Medical Implants·369 affected·Sep 26, 2025
High RiskFDA
Kico Knee Innovation Company
Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V20...
Medical Implants·21 affected·Sep 19, 2025
High RiskFDA
Theken Companies Llc
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar H...
Medical Implants·409 affected·Sep 11, 2025
High RiskFDA
Berkeley Advanced Biomaterials, Llc
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use...
Medical Implants·62 affected·Sep 2, 2025
High RiskFDA
S.i.n. Implant System Ltda
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5...
Medical Implants·4,367 affected·Jul 30, 2025
High RiskFDA
Ortoma Ab
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapt...
Medical Implants·261 affected·Jul 28, 2025
High RiskFDA
Dentsply Ih, Inc.
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis...
Medical Implants·780 affected·Jul 24, 2025
High RiskFDA
Dentsply Ih, Inc.
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product...
Medical Implants·102 affected·Jul 24, 2025
High RiskFDA
Encore Medical, Lp
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Des...
Medical Implants·439 affected·Jul 18, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Medical Implants·46 affected·Jul 15, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System use...
Medical Implants·24,583 affected·Jul 8, 2025
High RiskFDA
Boston Scientific Neuromodulation Corporation
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Medical Implants·25,260 affected·Jul 8, 2025